Events

Recall of HeartWare Ventricular Assist System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by HeartWare Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67684
  • Event Risk Class
    Class 2
  • Event Number
    Z-1607-2014
  • Event Initiated Date
    2014-04-16
  • Event Date Posted
    2014-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126064
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventricular (assisst) bypass - Product Code DSQ
  • Reason
    Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.
  • Action
    HeartWare sent an Urgent Medical Device Correction letter dated April 30, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to familiarize themselves with the letter and review their Patient Manual about proper power management. Discuss with their VAD Coordinator any questions they may have about the HeartWare System or the letter. Always keep two (2) power sources connected to your controller; never leave your controller connected to only one (1) power source except while briefly switching to another power source. " Review the recommended practices for power management provided later in this letter. If a battery shows any of the abnormal battery behaviors described, stop using that battery and contact your VAD Coordinator immediately to replace it. Customers were instructed to confirm that they have received and understood the information. Sign and return the enclosed Confirmation form as soon as they can to HeartWare in the prepaid self-addressed envelope or by fax to 1-305-364-2665. For questions customers were instructed to contact their doctor or VAD coordinator. For questions regarding this recall call 305-364-1575.

Device

HeartWare Ventricular Assist System
  • Model / Serial
    Catalog# USA:1650 // OUS: 1650, 1650-DE All HeartWare Battery Serial Numbers
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia and Internationally to Canada, Dominican Republic, Australia, Belgium, Italy, Germany, New Zeland, South Afica, Japan, Venezuela, Czech Republic, France, Switzerland, Brazil, UK, Saui Arabia, Taiwan, Slovakia, Luxemburg, Hong Kong, Lebano, India, Chile, Oldenburg, Israel, Netherlands, Croatia, Egypt, Turkey, Malaysia, Norway, Greece, Spain, Lithuania, Korea, Singapore, Poland, and Argentina.
  • Product Description
    HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery || For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
  • Manufacturer
    HeartWare Inc

Manufacturer

HeartWare Inc
  • Manufacturer Address
    HeartWare Inc, 14400 Nw 60th Ave, Miami Lakes FL 33014-2807
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA